Antibiotic Prophylaxis in Prosthetic Breast Reconstructions

December 13, 2013 updated by: Dr. Yasmin Maor, Sheba Medical Center
The added benefit of prolonged antibiotic prophylactic treatment in patients undergoing breast reconstruction who have drains placed for several days after surgery is controversial. In this study we aim to compare two prophylactic regimens: 1. 24 hour antibiotic treatment prior to surgery with cefazolin 2. a prolonged antibiotic regimen consisting of 48 hours cefazolin treatment followed by oral therapy with cephalexin until the removal of the drains. Patients will sign an informed consent form prior to the surgery and will be randomized to one of the antibiotic regimens. Patients will be closely followed up to one year after surgery. The number of surgical site infections according to the NNIS criteria and loss of breast implants will be compared between the two groups.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Tel Hashomer, Israel, 52621
        • Department of plastic surgery, Sheba medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

All criteria should be present:

  1. Signing an informed consent form
  2. Reconstructive breast surgery
  3. One drain or more remained after surgery -

Exclusion Criteria:

Age < 18 years Active infection at the surgical site at the operation time or in close proximity to the surgical site Immune deficiency state

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: short antibiotic course
Intravenous 2 gram cefazolin every 8 hours for 24 hours beginning at surgery
Drug: Short antibiotic course (standard of care)
Other Names:
  • Intravenous cefazolin 2 grams every 8 hours for 24 hours starting at surgery
Experimental: Prolonged antobiotic treatment
Intravenous 2 gram cefazolin every 8 hours for 48 hours starting at surgery followed by oral cefalexin 500 mg every 6 hours until removal of drains
Drug: Prolonged antibiotic treatment
Other Names:
  • Intravenous cefazolin 2 grams every 8 hours for 48 hours starting at surgery followed by oral cefalexin 500 mg every 6 hours until removal of drains

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical site infection
Time Frame: 1 year
The percentage and number of surgical site infections assessed according to the NNIS criteria up to one year after reconstructive breast surgery will be compared between the two groups
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Yasmin Maor, MD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 13, 2013

First Posted (Estimate)

December 16, 2013

Study Record Updates

Last Update Posted (Estimate)

December 16, 2013

Last Update Submitted That Met QC Criteria

December 13, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0447-13-SMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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